Press releases

MCRA Press Releases

Press Releases
Date
Teaser
09/13/17
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the medical device industry, is pleased to announce that it has been chosen to lead three separate training sessions with the FDA.
07/26/17
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization to the medical device industry, today announced that it has authored a new white paper, "The Potential FDA Impact of the 2018 Presidential Budget Request".
07/11/17
In an address given in Paris, France to delegates attending the 13th annual IMPLANTS conference on orthopedic innovation, U.S. executive David W. Lown advised that companies will be left behind in a crowded orthopedic market unless they adopt an integrated and compliant research, development, and commercial access strategy.
02/09/17
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the neuro-musculoskeletal and orthopedic industry, is pleased to announce that it has moved its headquarters in Washington, DC.
08/11/16
SANUWAVE Health, Inc. (OTCBB:SNWV) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) a de novo petition requesting Agency review and classification of the dermaPACE System for treating Diabetic Foot Ulcers (DFU) as a Class II device.
07/20/16
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA) to approve Cartiva, Inc.'s Synthetic Cartilage Implant (SCI) for the treatment of osteoarthritis in the first metatarsophalangeal (MTP) joint (the "great" or "big" toe).
03/01/16
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading medical device consulting firm and clinical research organization to the medical device industry that integrates five business value creators regulatory, reimbursement, clinical research, compliance and quality assurance, has hired David McGurl, former Food and Drug Administration (FDA) Premarket Senior Lead Reviewer, to join its regulatory team as a Director.
06/24/15
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful approvable decision by the U.S. Food and Drug Administration (FDA) for Wright Medical Group, Inc.'s (NASDAQ: WMGI) Augment® Bone Graft Premarket Approval Application (PMA)
11/06/14
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful approvable decision by the U.S. Food and Drug Administration (FDA) for Wright Medical Group, Inc.'s (NASDAQ: WMGI) Augment® Bone Graft Premarket Approval Application (PMA)
06/27/11
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), an independent medical technology consulting firm focusing on regulatory, clinical, intellectual
04/14/10
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), the leading musculoskeletal consulting firm, today announced an exclusive co-marketing
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MCRA IN CLIENT PRESS RELEASES

Press Releases
Date
Teaser
04/14/11
Small Bone Innovations, Inc. (SBi) announced today that nearly 1.3 million individuals in the state of Arizona covered by BlueCross BlueShield
04/11/11
Small Bone Innovations, Inc. (SBi) announced today that 1.7 million people nationwide covered by Coventry Health Care (NYSE: CVH)
03/28/11
Small Bone Innovations, Inc. (SBi) announced today the 9.6 million beneficiaries of the US Department of Defense TRICARE®
03/10/11
Small Bone Innovations, Inc. (SBi), an orthopedics company focused exclusively on serving patients and their physicians with
02/16/11
Small Bone Innovations, Inc. (SBi), an orthopedics company focused exclusively on serving patients and their physicians
2/11/11
Small Bone Innovations, Inc. (SBi), an orthopedics company focused exclusively on serving patients and their physicians
MCRA is not a law firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services